Approval Order StatementApproval for an extension of the shelf-life from 18 months to 20months for the 1ml syringe; an increase in the onoethylglycinexylidide (megx) impurity specification from 2. 5% to 3. 5% w/w of the label strength and total impurities from 3. 0% to 4. 3% of label strength.